Google
Trusted Resources: News & Events
Latest announcements and gatherings
Sancilio Pharmaceuticals Company, Inc. (SPCI) Receives Rare Pediatric Disease Designation From the US Food and Drug Administration for Altemia, a Treatment of Sickle Cell Disease (SCD) in Children
Sancilio Pharmaceuticals Company, Inc. (SPCI) today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to Altemia™ Soft Gelatin Capsules for the treatment of sickle cell disease (SCD) in children. Altemia™, a leading development program for SPCI, is being developed as an oral, once-a-day formulation for children between the ages of 5 – 17 with SCD.
“The FDA’s Rare Pediatric Disease designation for Altemia™, in addition to the previously granted Orphan Drug Designation, further stresses the Agency’s recognition that the SCD community faces a critical need for new treatments like Altemia™,” said Dr. Frederick Sancilio, President and Chief Executive Officer of SPCI. “We continue to make important progress in our clinical trial; a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Altemia™ in pediatric patients. We look forward to reporting top-line results from the study early in the fourth quarter, this year.”
+myBinderRelated Content
-
Hydroxyurea Use and Outcomes of Pregnancy in Sickle Cell DiseaseBackground: Hydroxyurea reduces pain cr...
-
Big Jump in Success for Sickle Cell TransplantsDoubling the dose of total-body irradiat...
-
Gene Therapy for Blood DisordersIn the context of intense scrutiny over ...
-
Sickle Cell Disease Association of America – Mobile Chapter, Inc.The Sickle Cell Disease Association of A...
-
What is a bone marrow stem cell transplant?http://www.sicklecelltransplantconsortiu...
-
Winfred C. Wang, MDDr. Winfred Wang is a pediatric hematolo...
-
Maria Grazia Roncarolo, MDMaria Grazia Roncarolo, MD is the co-dir...
To improve your experience on this site, we use cookies. This includes cookies essential for the basic functioning of our website, cookies for analytics purposes, and cookies enabling us to personalize site content. By clicking on 'Accept' or any content on this site, you agree that cookies can be placed. You may adjust your browser's cookie settings to suit your preferences. More Information
The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.
Powered by
Support for this site is provided by
This platform is made possible through a partnership with the Sickle Cell Disease Association of America, Inc. (SCDAA) and its member organizations. SCDAA's mission is to advocate for people affected by sickle cell conditions and empower community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.